We are pleased to inform you that we have successfully passed both audits and are now certified in accordance with ISO 9001:2015 and 13485:2016.
But what do the two certifications actually stand for, and what are their advantages for us and for you?
The ISO 9001:2015 certification is the most important standard in the quality management system. This norm stipulates the requirements that are to be satisfied by a quality management system in order to be awarded the certification. The implementation of the norm offers numerous operational advantages. Here, for instance, operational workflow sequences become more transparent, the error quota and the costs arising as a result are reduced, and customer satisfaction is sustainably improved.
ISO 13485:2016 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. “ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.
Audit was made by Quality Austria for SK-Telemed GmbH. You can also see certificates here: